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Challenges and opportunities of decentralized clinical trials

Decentralized clinical trials allow the development of new effective treatments through more inclusive and diverse clinical research.

Traditional clinical trials often include unrepresentative populations since minority groups, whether due to geographical limitations, lack of communication or even discrimination, are often excluded. This is one of the advantages of decentralized trials by having an intersectional and inclusive vision. In this way, barriers can be reduced to create more complete studies, attract more participants and also reduce research costs.

The main difference between traditional and decentralized trials is that the former require participants to regularly visit the site where the study is carried out and, on the other hand, decentralized trials combine the use of software, information technology and visits from professionals to the residence of the participants.

Similarly, decentralized clinical trials imply new challenges, such as closing the digital divide, standardizing procedures and the need to create a new infrastructure. In other words, there is great diversity in the challenges related to the adoption of this type of assay, however, it is to overcome even greater challenges in clinical research, such as underrepresentation.

The US Food and Drug Administration (FDA) has explained that decentralized clinical trials "can ease the burden of participating in a clinical trial and potentially improve recruitment and retention of diverse participants."

One of the advantages of decentralized trials is digital recruitment, since it can achieve the elimination of certain geographical limitations for study participants and also provides benefits for participants such as managing their time so as not to interfere with their usual activities.

“Another common element of DCT approaches is electronic informed consent (eConsent), a feature that can be supported by a series of video vignettes, which explain the study in an engaging format,” explains an article published in npj Digital Medicine. . In this way, patients interact with electronic consent solutions, without feeling pressured to read and understand long, printed documents used in traditional trials.

Learn more about the challenges and opportunities of decentralized clinical trials at the following link: https://www.nature.com/articles/s41746-022-00603-y

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